Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
NCT06577532 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2025-05-21
Summary
The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.
Conditions
- Pancreatic Neoplasms
- Other Solid Tumors
Interventions
- DRUG
-
ABO2102
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
- DRUG
-
Toripalimab
Anti-PD-1 antibody, administered intravenously
Sponsors & Collaborators
-
Suzhou Abogen Biosciences Co., Ltd.
collaborator INDUSTRY -
Ruijin Hospital
lead OTHER
Principal Investigators
-
Baiyong Shen · Ruijin Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-24
- Primary Completion
- 2026-12-31
- Completion
- 2027-08-31
Countries
- China
Study Locations
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